Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments

Marta Peciña, MD PhD1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2026年5月15日最近更新: 2026年5月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 200
试验地点: 1
主要终点: Bold Signal Change in the Salience Network During the fMRI Experiment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical trial is to learn how different types of non-invasive brain stimulation affect mood and brain function in adults with major depressive disorder (MDD). It will also study how brain stimulation may work together with antidepressant treatments.

The main questions this study aims to answer are:

How do different patterns of brain stimulation affect mood in people with depression?

Do brain networks involved in emotion and self-reflection respond differently depending on the type of stimulation?

What are the combined effects of brain stimulation and antidepressant treatments on mood and brain activity?

Researchers will compare different brain stimulation patterns and target areas to understand their individual and combined effects.

Participants will:

Receive three types of brain stimulation (intermittent, continuous, and sham) in different sessions

Undergo MRI scans during the administration of either a fast-acting or conventional antidepressant.

Complete mood assessments during the scan and for one week after each session

This study may help identify brain-based strategies to improve treatment for depression.

In addition, a subset of participants (~10) will complete a reward-guided decision-making fMRI task for feasibility purposes.

详细描述

This mechanistic clinical trial will investigate the role of large-scale brain networks in modulating mood responses in adults with major depressive disorder (MDD) using non-invasive neuromodulation and neuroimaging. The study will focus on the salience network (SN), default mode network (DMN), and functional connectivity (FC) between them, given prior evidence linking these systems to mood regulation and antidepressant response.

Using a 2x3 factorial design, 200 participants with MDD will be randomized to receive theta burst stimulation (TBS) targeting either the SN or the DMN (between-subject factor). Each participant will complete three within-subject TBS sessions one week apart: intermittent TBS (iTBS), continuous TBS (cTBS), and sham stimulation. TBS will be delivered over individualized fMRI-based targets derived from prior resting-state connectivity maps.

Following each stimulation session, participants will complete an MRI protocol that includes administration of either a fast-acting or conventional antidepressant, as well as resting-state functional imaging. In addition, a subset of participants (~10) will complete a reward learning fMRI task, a reward-guided decision-making, designed to capture value-based decision-making processes.

Primary neural outcomes include changes in activation and connectivity within and between SN and DMN regions, measured using task-based and resting-state fMRI. Behavioral outcomes include mood ratings acquired repeatedly during the scanning session and via daily remote assessments for one week post-stimulation.

This design allows for within-subject comparison of the acute and sub-acute effects of different TBS patterns, and between-subject comparison of SN- vs. DMN-targeted stimulation. The study aims to identify brain circuits that can be engaged or modulated to enhance treatment response in depression, with the longer-term goal of informing precision neuromodulation strategies.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Other
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adults ages 18-55 (~60% female).
•Diagnosis of Major Depressive Disorder (MDD) with or without comorbid anxiety disorders (e.g., panic disorder) or Axis II disorders.
•Psychotropic-free at enrollment.

排除标准

•being pregnant or breastfeeding;
•diagnosis of psychotic depression, schizophrenia, bipolar disorder, or other Axis I disorders, except for anxiety disorders;
•severe substance use (excluding nicotine) in the last 2 months as determined by using the MINI, a structured interview that uses the Diagnostic and Statistical Manual of Mental Disorders;
•requiring immediate hospitalization;
•epilepsy or conditions requiring an anticonvulsant;
•receiving vagus nerve stimulation, electroconvulsive therapy (ECT), or TMS in the last 2 months;
•currently taking or have taken within the last 21 days psychiatric medication or augmenting agents;
•receiving depression-specific psychotherapy;
•actively suicidal or considered a high suicide risk;
•enrolled in another study; or
•MRI/TMS contraindication as determined by the fMRI and TMS screening questionnaires